Asset Management System Certification Renewal Audit

Following the ISO 55001:2014 Asset Management System Certification Audit conducted in December 2021, our comprehensive asset management system—encompassing both tangible and intangible assets utilized in pharmaceutical production—was officially certified by ICAS (International Conformity Assessment Service Inc.), a subsidiary of the Turkish Standards Institute (TSE). PharmaVision proudly became the first company in the Turkish pharmaceutical industry to achieve this prestigious certification.

 

On December 4-5, 2024, a certification renewal audit was conducted by a team of five auditors from TSE Global (the new name for ICAS). As a result of this audit, it has been determined that PharmaVision’s ISO 55001 Asset Management System Certificate will be renewed.

 

The auditors expressed satisfaction with the widespread adoption of the asset management system across the departments they assessed and commended the demonstrated level of awareness within the organization. Additionally, they specifically acknowledged exemplary practices, including the collaborative efforts of the Material Management and Production Planning Department with the Accounting and Finance Department in operational planning, the in-house software solutions developed by the IT Department, and the proactive initiatives undertaken by the Responsible Care Department with regard to climate change, which were all recognized as best practices.

 

The updated ISO 55001:2024 standard was officially published by the International Organization for Standardization (ISO) on July 3, 2024 (in English). However, the certification renewal audit for PharmaVision was conducted in accordance with the 2014 version of the standard. As a result of our correspondence with ISO, we actively participated in the Mirror Technical Committee (MTC 183 Facility Management – subgroup ISO/TC 251 Asset Management) and obtained the ISO/FDIS 55001 (Final Draft) from TSE for review. We have since thoroughly examined our procedures and strategic asset management plan. Once the 2024 version of the standard is translated into Turkish by TSE, we will procure the updated standard and re-evaluate our system and practices accordingly.

 

In line with our ongoing commitment to excellence, we will continue to optimize the use of machinery, equipment, and human resources to adhere to the highest standards of quality—surpassing even the rigorous requirements of current Good Manufacturing Practices (cGMP). Through the implementation of effective operational procedures, we aim to deliver superior value to our company while minimizing costs through proactive, predictive measures.

 

We will continue to measure the Overall Equipment Effectiveness (OEE) of our production and packaging lines on a daily basis, interpret the results and increase our efficiency with the measures taken. For capital expenditures, particularly regarding the acquisition of machinery and physical assets, we remain steadfast in our approach of making informed, strategic decisions. We take into account not only the initial investment costs (CapEx) but also the full spectrum of operational costs (OpEx), such as maintenance, repair, and energy expenses, throughout the asset’s lifecycle. This approach ensures that all decisions are made based on a Total Cost of Ownership (TCO) analysis.

 

In conclusion, we wish to extend our deepest gratitude to all colleagues who have contributed to the creation, development, and continued maturation of this holistic and inclusive management system. We are committed to the ongoing enhancement of the Asset Management System with the active participation of all our employees.